Sixty five critically ill Covid-19 patients have been enrolled in a multi-centre clinical trial across the country to assess the safety and efficacy of convalescent plasma therapy.
So far, 34 patients have received plasma therapy, and three have succumbed to the infection, said Dr R R Gangakhedkar, head of Epidemiology and Communicable Disease division of the Indian Council of Medical Research (ICMR). “The study had received the go-ahead from the Covid-19 National Ethics Committee on April 29 and the duration of the trial is estimated to be six months,” he told The Indian Express.
The therapy has been in the news after a critically ill 47-year-old woman in Pune received it and reportedly recovered. The woman, who has co-morbidities like hypertension, hypothyroidism and obesity, continues to be under observation at Sassoon General Hospital.
Sassoon General Hospital is one of the 21 medical facilities in the country included in the clinical trial named PLACID – Phase II Open Label Randomised Controlled Trial to assess the efficacy and safety of convalescent plasma to limit COVID-19 associated complications in moderate disease’.
The ICMR shortlist of 21 institutes for PLACID trial includes five hospitals in Maharashtra, four in Gujarat, two each in Rajasthan, Tamil Nadu, Madhya Pradesh and Uttar Pradesh, and one each in Punjab, Karnataka, Telangana and Chandigarh.
Plasma is the liquid in the blood that holds blood cells, and it is obtained by separating the cells from the liquid, as explained by Arturo Casadevall from the Johns Hopkins School of Public Health, at a recent webinar on convalescent plasma for prophylaxis and treatment of Covid-19.
According to experts, this therapy involves taking antibodies from the blood of a person who has recovered from Covid-19 and transfusing those antibodies into an active coronavirus patient, to help kick-start the immune system to fight the infection.
ICMR researchers said the sample size for the study is 452. Once 400 patients are enrolled, no more sites will be added. Several hospitals have applied to be part of the trial, said a researcher, adding that if someone wanted to donate plasma for the benefit of the clinical trial, they should do so.
However, the Union Health Ministry has cautioned that there is not enough evidence yet to claim that plasma therapy could be used for the treatment of the disease.
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